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NCT ID: NCT03922386 Completed - Bradycardia Clinical Trials

Safety and Electrical Performances of XFINE Leads

PERSEPOLIS
Start date: September 9, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

NCT ID: NCT03922308 Completed - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Study of rADAMTS-13 (SHP655) in the Treatment of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

SOAR-HI
Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP) participants.

NCT ID: NCT03921905 Completed - Clinical trials for Peripheral Artery Disease

Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.

PAD&CAD
Start date: September 25, 2019
Phase:
Study type: Observational

Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.

NCT ID: NCT03921541 Completed - Hyperargininemia Clinical Trials

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

Start date: April 10, 2019
Phase: Phase 3
Study type: Interventional

CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

NCT ID: NCT03921528 Completed - Clinical trials for Neuromuscular Diseases

An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy

TOPAZ
Start date: April 22, 2019
Phase: Phase 2
Study type: Interventional

The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.

NCT ID: NCT03920293 Completed - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Start date: March 12, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

NCT ID: NCT03920189 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Echocardiographic Evaluation in ARDS Patients

Start date: September 1, 2018
Phase:
Study type: Observational

The purpose of this study is to assess the left diastolic function at different levels of in patients affected by the acute respiratory distress syndrome (ARDS)

NCT ID: NCT03920072 Completed - Clinical trials for X-linked Hypophosphatemia

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

NCT ID: NCT03919604 Completed - Cystic Fibrosis Clinical Trials

ECMO for Lung Transplantation in Cystic Fibrosis Patients

RetroLUTX
Start date: January 1, 2013
Phase:
Study type: Observational

Cystic fibrosis (CF) is the most common genetically inherited disease in the Caucasian population. Bilateral lung transplantation (LUTX) is a viable option for these patients. Frequently, the surgical operation of LUTX is complicated by hemodynamic instability, intractable hypoxia and respiratory acidosis. For these reasons, Intraoperative extracorporeal life support - ECLS- is required. Data on predictors of use of intraoperative ECLS in CF patients undergoing LUTX is scarce. Aim of this retrospective observational study was 1) to find possible risk factors at the time of enlistment associated with the intraoperative use of ECLS and 2) to compare the outcomes of CF patients treated with ECLS during LUTX or not.

NCT ID: NCT03919019 Completed - Dry AMD Clinical Trials

Morpho-functional Changes After Oral Supplementation of Antioxidants and Anti-inflammatory Treatment in Age-Related Macular Degeneration.

MACUPREV
Start date: January 18, 2018
Phase: N/A
Study type: Interventional

In patients with AMD a deterioration of the antioxidant mechanisms of the retina is observed and therefore an increase in the production of free radicals responsible for tissue damage. The Age-Related Eye Disease Study (AREDS) found that the intake of antioxidants reduces the risk of progression of the disease to an advanced stage (choroidal neovascularization or geographic atrophy ) and reduces the loss of visual acuity. In this study the investigators want to analyze the functional retinal changes (mfERG) of the macular region, in patients with dry age-related macular degeneration, after the use for 6 months of an oral supplementation based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.